A Source of Quality and Regulatory Innovation
I am a Regulatory Affairs and Quality Management professional with over 25 years’ experience in the bio pharmaceutical and Medical devices industries.
Almost all projects in which I have been involved have been at the cutting edge of technology. As a regulatory professional and a quality management systems designer I have innovated both in Regulatory and Quality Management areas to achieve the most efficient pathway for products to market.
As an individual I have a very strong emphasis on getting things done. I like to see a finished product of which I can be proud.
I am a technical/technology oriented regulatory professional who can absorb technical detail and find appropriate regulatory/quality arguments. I have above all enjoyed this aspect of my work the most and have successfully used this ability to best effect in many projects.
I genuinely enjoy working within multidisciplinary teams and interacting and communicating with people at all levels. I consider this to be one of my true strengths.
My career, spanning an era during which biotechnology moved from a word used in the laboratory to a mainstream industry, has afforded me the opportunity to gain cross functional experience in product development and pre and post marketing CMC in biopharmaceuticals, as well as inception, design, development and manufacture in combination/class IIb/class III medical devices.
I have worked as an integrated part of teams in projects with several major and medium sized pharmaceutical and medical device companies. These include Bristol Myers Squibb, GSK, Abbott, Merck Serono, CSL, Macopharma and Octapharma.
I have also worked closely with national and quasi-national organisations such as the National Blood Service and the American Red Cross for whom I designed a quality system.
A large part of my experience has been hands on. Consequently, I have first-hand familiarity with development and CMC part of the product life cycle (both pre and post approval) in the field of biopharmaceuticals and familiarity with the whole of product life cycle in medical devices.
I have also designed and developed bespoke quality management systems to ISO9000, ISO 13485 and ISO 15189 standards.
Pirus Consulting is a company I have formed to offer my experience in these areas to the biopharmaceutical and medical devices industries.